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Director Regulatory Affairs, US Advertising and Promotion
Posted 09 Mar 2023
Rockland, Massachusetts - United States
Req Id 261912
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
The Senior Director of Advertising and Promotion, Prescription Drug Products, may manages one or more Regulatory Affairs Ad & Promo reviewers and provide Regulatory advice and risk assessment on cross functional promotional review team(s) for core product(s). The Senior Director is responsible for ensuring promotinal and advertising materials are in compliance with all applicable laws, regulations, regulatory agency guidance and EMD Serono standards. This position will be the primary contact for OPDP, provide internal training and SOP development and review guidance. Senior Director will be responsible for providing advise and guidance to development teams on clinical study design and strategic advice on claims support and label development.
Key Activities/ Responsibilities:
- Manages one or more promotional reviewers for prescription drugs who represent Regulatory Affairs on the promotional review committees for marketed products. Provides strategic guidance, oversight, and training to regulatory promotional reviewers. This position will require reviewing promotional materials.
- Provides strategic support and guidance on proposed claims for products in development and development of Important Safety Information (ISI) and Brief Summaries.
- Responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives.
- Continually develops, assesses and revises advertising and promotion-related processes and SOPs as needed, to enhance efficiencies and compliance.
- Regularly monitors the regulatory compliance trends in industry, interprets new regulations, guidance documents and enforcement letters. Updates the Regulatory Ad Promo staff, promotional review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP), Advertising and Promotion Labeling Branch (APLB), and other regulatory considerations that may impact business.
- Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.
- Works closely with US and Global Regulatory Affairs Therapy area leads to advice on protocol design and impact on promotional labeling and advertising.
- Reviews packages for regulatory advice, resolution of FDA action letters and leads the company in discussions with OPDP.
- Coordinates Companywide ongoing regulatory training on regulatory issues pertaining to promotion of Company prescription products.
- Other job responsibilities as needed.
Who You Are:
- Bachelor’s degree in scientific, medical or business discipline
- Minimum of 14 years of relevant pharmaceutical industry experience with 10+ years of relevant Regulatory Affairs with at least 7 years of experience with prescription product advertising and promotion review.
- Supervisory experience.
- Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
- Advanced degree (MS, PharmD, MD, PhD, JD) preferred.
- Experience in as Regulatory Strategy and or Labeling Strategy
- Direct to consumer advertising experience
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html